在ADVIA 1650分析仪上对一种用于卡马西平的新型比浊免疫分析法进行分析性能评估：卡马西平10,11-环氧化物的影响。

Analytic performance evaluation of a new turbidimetric immunoassay for carbamazepine on the ADVIA 1650 analyzer: effect of carbamazepine 10,11-epoxide.

作者信息

Dasgupta Amitava, Datta Pradip

机构信息

Department of Pathology and Laboratory Medicine, University of Texas-Houston Medical School, Houston, TX 77030, USA.

出版信息

Ther Drug Monit. 2005 Feb;27(1):31-4. doi: 10.1097/00007691-200502000-00007.

DOI:10.1097/00007691-200502000-00007

PMID:15665743

Abstract

Carbamazepine, an anticonvulsant, requires therapeutic drug monitoring. Recently Bayer HealthCare, Diagnostics Division released a turbidimetric immunoassay of carbamazepine on the ADVIA 1650 analyzer. We evaluated the analytic performance of this assay by comparing values obtained with this new assay in sera of 54 patients receiving carbamazepine with the values obtained by using a widely used fluorescence polarization immunoassay (FPIA) and a chemiluminescent immunoassay (CLIA). The new turbidimetric immunoassay for carbamazepine showed excellent precision. The low control showed a total CV of 4.9% (mean 2.86, SD 0.14 microg/mL), the medium control demonstrated a total CV of 3.5% (mean 7.79, SD 0.27 microg/mL), and the high control showed a total CV of 4.8% (mean 16.15, SD 0.78 microg/mL). The assay was linear up to a carbamazepine concentration of 20 microg/mL. The assay showed excellent dilution recovery and recovery of samples supplemented with carbamazepine (mean recovery 102.2%). We observed an excellent correlation between the values obtained by the FPIA (x-axis) assay and the new turbidimetric (y-axis) assay (y = 0.96 x - 0.46, r = 0.99, n = 54). We also observed excellent correlation between the values obtained by the CLIA (x-axis) and the turbidimetric (y-axis) assay (y = 1.10 x -0.32, r = 0.99, n = 54). However, the slope of 1.10 was higher than the slope of 0.96 observed with the regression equation obtained by using values obtained by the FPIA and the turbidimetric assay. The positive bias obtained with the new turbidimetric assay compared with the CLIA assay resulted from lower cross reactivity of carbamazepine 10,11-epoxide, the active metabolite of carbamazepine, with CLIA. On the other hand, the cross reactivity of the metabolite is similar between the new turbidimetric assay and the FPIA assay. We conclude that the new turbidimetric assay can be used for routine monitoring of carbamazepine in clinical laboratories.

摘要

卡马西平作为一种抗惊厥药，需要进行治疗药物监测。最近，拜耳医疗保健诊断部门在ADVIA 1650分析仪上推出了一种卡马西平的比浊免疫测定法。我们通过比较54例接受卡马西平治疗患者血清中该新测定法得到的值与使用广泛应用的荧光偏振免疫测定法（FPIA）和化学发光免疫测定法（CLIA）得到的值，来评估该测定法的分析性能。新的卡马西平比浊免疫测定法显示出优异的精密度。低浓度质控品的总变异系数（CV）为4.9%（均值2.86，标准差0.14μg/mL），中浓度质控品的总CV为3.5%（均值7.79，标准差0.27μg/mL），高浓度质控品的总CV为4.8%（均值16.15，标准差0.78μg/mL）。该测定法在卡马西平浓度达20μg/mL时呈线性。该测定法显示出优异的稀释回收率以及添加卡马西平的样品回收率（平均回收率102.2%）。我们观察到FPIA测定法（x轴）得到的值与新的比浊测定法（y轴）得到的值之间具有极好的相关性（y = 0.96x - 0.46，r = 0.99，n = 54）。我们还观察到CLIA测定法（x轴）与比浊测定法（y轴）得到的值之间具有极好的相关性（y = 1.10x - 0.32，r = 0.99，n = 54）。然而，1.10的斜率高于使用FPIA测定法和比浊测定法得到的值所获得回归方程中观察到的0.96的斜率。与CLIA测定法相比，新的比浊测定法出现的正偏差是由于卡马西平的活性代谢物卡马西平10,11 - 环氧化物与CLIA的交叉反应性较低。另一方面，该代谢物在新的比浊测定法和FPIA测定法之间的交叉反应性相似。我们得出结论，新的比浊测定法可用于临床实验室对卡马西平的常规监测。